Actively Recruiting
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Led by Indiana University · Updated on 2025-07-31
120
Participants Needed
2
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.
CONDITIONS
Official Title
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Ability to provide written informed consent and HIPAA authorization
- ECOG performance status of 0 to 2
- Primary tumor located in the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior oropharynx walls)
- Histologically confirmed squamous cell carcinoma
- Detectable ctHPVDNA from blood samples before treatment
- Tumor that is resectable and accessible with high chance of negative surgical margins
- Includes both smokers and non-smokers
- Tumor stage T1 or T2, or select T3 tumors that are mobile and do not invade the larynx
- Nodal stage N0, N1, or N2
- Mobile neck lymph nodes on physical exam if nodes are positive
- HPV-positive tumor confirmed by p16, in-situ hybridization, PCR, or ctHPVDNA
- Subjects with unknown primaries included if primary is found and resectable with negative margins, or if tonsils are fully resected and proven negative
You will not qualify if you...
- Serious medical conditions that prevent general anesthesia for surgery
- Previous head and neck radiation or head and neck cancer within 3 years
- Presence of distant metastatic disease
- Having synchronous HPV-positive oropharynx primary cancers
- Prior invasive cancer within 3 years except non-melanoma skin cancer or thyroid cancer unless considered cured or disease free
- Lactating or pregnant women
- Women of childbearing potential must have a negative pregnancy test on surgery day unless they have had hysterectomy, bilateral oophorectomy, or have been naturally amenorrheic for at least 12 consecutive months
AI-Screening
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Trial Site Locations
Total: 2 locations
1
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Azeezat Yekinni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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